FDA.reportPublic FDA data

NDC 52389-325-01 - Diurex

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52389-325
Requested NDC
52389-325-01
Package NDCs from labels
52389-325-01, 52389-325-42, 52389-325-21
Manufacturer
Alva-Amco Pharmacal Companies, Inc.
Effective date
2024-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diurex CapsulesAlva-Amco Pharmacal Companies, Inc.2024-05-15HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-325DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]8Legacy NDC20240517_ab10451e-ff87-4974-bec4-7ba19c5bbe65.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PamabromACTIVE INGREDIENTUA8U0KJM72DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PamabromACTIVE MOIETYUA8U0KJM72DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Citric acidINACTIVE INGREDIENT2968PHW8QPDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Magnesium oxideINACTIVE INGREDIENT3A3U0GI71GDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PovidoneINACTIVE INGREDIENTFZ989GH94EDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
RiboflavinINACTIVE INGREDIENTTLM2976OFRDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
ShellacINACTIVE INGREDIENT46N107B71ODIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
SucroseINACTIVE INGREDIENTC151H8M554DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
TalcINACTIVE INGREDIENT7SEV7J4R1UDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 126 · 2,520 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Prenate MiniASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRYAvion Pharmaceuticals, LLC8ab766c2-d554-4141-92b2-fbe038e80c9f2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Prenate EssentialASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENTAvion Pharmaceuticals, LLCe5acfb2a-0959-4542-9b4c-790be194d5812026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Prenate Elite.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAvion Pharmaceuticals, LLC9b79c950-4312-4a53-9e36-fb8e00b053df2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: TLM2976OFR
unii: 3A3U0GI71G
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: TLM2976OFR
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Diurex UltimateCAFFEINEKobayashi Healthcare International, Inc.c6debbfe-6061-463f-8f17-fb240c6f1bab2026-06-08WarningsExact identifier
application number: M027
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
VitaluxMULTIVITAMINPureTek Corporation52d5eee7-8146-cc62-e063-6394a90a8c3f2026-06-02Boxed warning, Adverse reactionsExact identifier
unii: TLM2976OFR
unii: 3A3U0GI71G
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.